SGLT-2 Inhibitors in Prevention of Post-procedural Renal and Cardiovascular Complications aFter PCI Among Patients With Diabetes Mellitus and Coronary Artery Disease: a Prospective, Randomized, Pilot Study (SAFE-PCI)

NCT05037695 | Unknown Phase 4

• 1 other identifier: SAFE-PCI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with type 2 diabetes mellitus (DM) have higher risk of major cardiovascular events (MACE) and renal disfunction. The Sodium-glucose cotransporter-2 inhibitors (iSGLT2) reduces hyperglycemia in patients with type 2 DM and have multiple metabolic effects, lowering primary composite cardiovascular outcomes and progression to renal failure. 25% of patients with Stable Ischemic Heart Disease (SIHD) undergoing PCI are diabetics being one of the most prevalent and important risk factors for the development of contrast induced nephropathy (CIN). The occurence of CIN is associated with higher rates of death, loss of renal function, necessity of dialysis and increase of health care costs. In this pilot study we sought to evaluate if the iSGLT2 would prevent periprocedural complications - such as periprocedural CIN and MI - in type 2 DM patients undergoing PCI through the assessment of renal and myocardial biomarkers

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease; Acute Kidney Injury

Keywords

PCI

Outcome Measures

Primary Outcomes (8)

• Serum creatinine values in pre-specified periods

  Delta and area under curve

  Pre PCI

• Serum creatinine values in pre-specified periods

  Delta and area under curve

  Day 1

• Serum creatinine values in pre-specified periods

  Delta and area under curve

  Day 2

• Serum creatinine values in pre-specified periods

  Delta and area under curve

  Day 30

• NGAL values in pre-specified periods

  Delta and area under curve

  Pre PCI

• NGAL values in pre-specified periods

  Delta and area under curve

  Day 1

• NGAL values in pre-specified periods

  Delta and area under curve

  Day 2

• NGAL values in pre-specified periods

  Delta and area under curve

  Day 30

Secondary Outcomes (9)

• Increase in serum creatinine ≥ 0.3 mg/dl or 50% from the baseline value, within 48 hours after the index procedure

  48 hours after PCI

• Biomarkers elevation ≥10 upper reference limit (URL) for creatine kinase MB (CKMB) and/or ≥70 URL for troponin

  24 hours after PCI

• Occurrence of definite or probable stent thrombosis

  Until 30 days

• Death From Cardiovascular Causes

  Until 30 days

• Myocardial Infarction

  Until 30 days

Study Arms (2)

empagliflozin + OMT

EXPERIMENTAL

empagliflozin 25mg - Daily - at least 15 days before the PCI procedure OMT - Optimized Medical Therapy - conventional drug therapy with oral antidiabetics and/or insulin plus use of anti-platelet, anti-hypertensive and lipid-lowering agents necessary to obtain adequate values for pressure, lipid control and glycemia, in accordance with international guidelines and protocols. Strategies to reduce Contrast-induced acute kidney injury will be used in both study arms

Drug: empagliflozin 25 MG

OMT

NO INTERVENTION

OMT - Optimized Medical Therapy - conventional drug therapy with oral antidiabetics and/or insulin plus use of anti-platelet, anti-hypertensive and lipid-lowering agents necessary to obtain adequate values for pressure, lipid control and glycemia, in accordance with international guidelines and protocols. Strategies to reduce Contrast-induced acute kidney injury will be used in both study arms

Interventions

empagliflozin 25 MG DRUG

empagliflozin 25mg - daily

empagliflozin + OMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Type II Diabetes mellitus
• Finding of obstructive coronary artery disease (≥50% stenosis in major epicardial vessel) and clinical indication of percutaneous coronary intervention.(PCI)
• Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
• Participant is willing to give written informed consent

You may not qualify if:

• Estimated glomerular filtration rate (eGFR) \< 30mL/min/1,73m2 or dialysis
• Inability to comply with the protocol
• Urgent need for PCI
• Acute coronary syndrome within the previous 30 days
• Use of iodinated contrast or other nephrotoxic agents \< 7 days
• Angina after coronary bypass surgery
• Canadian Cardiovascular Society Class IV angina, including unprovoked rest angina
• Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
• Pregnancy

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coracao - HCFMUSP

São Paulo, 05403000, Brazil

RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease; Acute Kidney Injury

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Mateus P Feitosa, MD

  Instituto do Coracao - HCFMUSP

  PRINCIPAL INVESTIGATOR

• Carlos V Serrano, MD

  Instituto do Coracao - HCFMUSP

  STUDY DIRECTOR

Central Study Contacts

Mateus P Feitosa, MD

CONTACT

55-85-997734072; mateusfeitosa@hotmail.com

Carlos V Serrano, MD

CONTACT

55-11-26615352; carlos.serrano@incor.usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Prospective, unblinded, randomized (1:1), single-center pilot study of 40 patients allocated to one of the treatment arms (OMT + empagliflozin or OMT).

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: September 8, 2021
• Study Start: July 21, 2021
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)